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Trial Outcomes & Findings for Modafinil for Methamphetamine Dependence (NCT NCT00859573)

NCT ID: NCT00859573

Last Updated: 2017-11-21

Results Overview

Number of negative drug screens for methamphetamine during the study (every negative drug screen obtained is counted as 1 negative drug screen)divided by the total possible number of drug screens during the 6 week post residential phase of trial(participants provided 3 drug screens per week so the expected number of drug screens total is 18.This does include week 8. Missing drug screens are counted as positive.# negative drug screens/18. Minimum score is 0 and maximum score is 1. The higher the score the better the outcome. The mean of the individual treatment effectiveness scores is reported.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

thrice weekly from week 3 through week 8

Results posted on

2017-11-21

Participant Flow

A total of 20 participants were recruited into the study between 5/26/2009 and 3/30/2010. However, only 9 participants entered the study with 11 dropping out during the consent or intake process. They were recruited from newspaper advertisements and word-of-mouth advertising and who meet the following criteria.

Participant milestones

Participant milestones
Measure
Modafinil
Modafinil 400mg orally once daily
Placebo
Two placebo tablets orally once daily
Overall Study
STARTED
6
3
Overall Study
COMPLETED
1
1
Overall Study
NOT COMPLETED
5
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Modafinil
Modafinil 400mg orally once daily
Placebo
Two placebo tablets orally once daily
Overall Study
Withdrawal by Subject
4
1
Overall Study
Physician Decision
1
1

Baseline Characteristics

Modafinil for Methamphetamine Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Modafinil
n=6 Participants
Modafinil 400mg orally once daily
Placebo
n=3 Participants
Two placebo tablets orally once daily
Total
n=9 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
n=5 Participants
3 Participants
n=7 Participants
9 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
29.25 years
STANDARD_DEVIATION 2.87 • n=5 Participants
35.88 years
STANDARD_DEVIATION 12.15 • n=7 Participants
32.56 years
STANDARD_DEVIATION 9.19 • n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
1 Participants
n=7 Participants
4 Participants
n=5 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Region of Enrollment
United States
6 participants
n=5 Participants
3 participants
n=7 Participants
9 participants
n=5 Participants

PRIMARY outcome

Timeframe: thrice weekly from week 3 through week 8

Population: Participants that completed the 2 week residential treatment and entered the outpatient phase with intent to treat and missing urines treated as positive urines.

Number of negative drug screens for methamphetamine during the study (every negative drug screen obtained is counted as 1 negative drug screen)divided by the total possible number of drug screens during the 6 week post residential phase of trial(participants provided 3 drug screens per week so the expected number of drug screens total is 18.This does include week 8. Missing drug screens are counted as positive.# negative drug screens/18. Minimum score is 0 and maximum score is 1. The higher the score the better the outcome. The mean of the individual treatment effectiveness scores is reported.

Outcome measures

Outcome measures
Measure
Placebo
n=2 Participants
Participants received 2 capsules placebo orally daily
Modafinil
n=3 Participants
Modafinil 400mg orally daily
Mean Treatment Effectiveness Scores
0.5625 scores on a scale
Standard Deviation 0.38
.333 scores on a scale
Standard Deviation .31

Adverse Events

Modafinil

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Modafinil
n=6 participants at risk
Modafinil 400mg orally once daily
Placebo
n=3 participants at risk
Two placebo tablets orally once daily
Psychiatric disorders
Anxiety
16.7%
1/6 • Number of events 1
0.00%
0/3
Psychiatric disorders
Insomnia
33.3%
2/6 • Number of events 2
0.00%
0/3
Nervous system disorders
Headache
33.3%
2/6 • Number of events 2
66.7%
2/3 • Number of events 2
Metabolism and nutrition disorders
Weight loss
16.7%
1/6 • Number of events 1
0.00%
0/3
Gastrointestinal disorders
Nausea
0.00%
0/6
33.3%
1/3 • Number of events 1

Additional Information

Michael J. Mancino, M.D.

University of Arkansas for Medical Sciences

Phone: 501-526-8442

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place